ICP-MS法测定氨甲环酸注射液中26种元素杂质含量  

Quantitative determination of 26 elemental impurities in tranexamic acid injection by ICP-MS

作　　者：邱怡婷 成婕 任锟 郭燕燕 黄琬莎 江燕 QIU Yi-ting;CHENG Jie;REN Kun;GUO Yan-yan;HUANG Wan-sha;JIANG Yan(Sichuan Institute for Drug Control(Sichuan Testing Center for Medical Devices),Chengdu 611731,China)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心),四川成都611731

出　　处：《化学研究与应用》2023年第11期2801-2808,共8页Chemical Research and Application

摘　　要：建立同时测定氨甲环酸注射液中26种元素杂质(锂、硼、镁、铝、硅、钙、钛、钒、铬、锰、铁、钴、镍、铜、锌、砷、钼、钯、镉、锡、锑、钡、铈、铂、汞、铅)含量的电感耦合等离子体质谱法。样品经稀释后,采用ICP-MS法测定16批不同厂家生产的氨甲环酸注射液样品,以Sc、Ge、Rh、In、Bi元素为内标。26种元素线性关系均良好,相关系数r>0.999,各元素的平均回收率为89.4%~115.6%(n=9),RSD<7.4%(n=9)。26种金属元素的方法检测限为0.0004~0.14μg·mL^(-1)。该方法简便有效,具有良好的灵敏度和准确度,可用于氨甲环酸注射液中26种元素杂质迁移量的同时测定。To establish a method for the determination of 26 elemental impurities(Li,B,Mg,Al,Si,Ca,Ti,V,Cr,Mn,Fe,Co,Ni,Cu,Zn,As,Mo,Pd,Cd,Sn,Sb,Ba,Ce,Pt,Hg,Pb)in tranexamic acid injection by inductively coupled plasma mass spectrometry(ICP-MS).Samples were determined after dilution,with Sc,Ge,Rh,In and Bi as the internal standard elements.Each element had a good linear relationship within the corresponding concentration range(r≥0.999).The recoveries were in the range of 89.4%~115.6%,with these RSDs<7.4%(n=9).The detection limit of the method was 0.0004~0.14μg·mL^(-1).The method is conven-ient,effective,sensitive and accurate,and can be used for the simultaneous determination of 26 elemental impurities in tranexamic acid injection.

关 键 词：电感耦合等离子体质谱法 元素杂质 氨甲环酸注射液 

分 类 号：O657.31[理学—分析化学]